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  • Helicobacter pylori first-line and rescue treatments in the presence of penicillin allergy.

Helicobacter pylori first-line and rescue treatments in the presence of penicillin allergy.

Digestive diseases and sciences (2014-09-23)
Javier P Gisbert, Jesús Barrio, Inés Modolell, Javier Molina-Infante, Angeles Perez Aisa, Manuel Castro-Fernández, Luis Rodrigo, Angel Cosme, Jose Luis Gisbert, Miguel Fernández-Bermejo, Santiago Marcos, Alicia C Marín, Adrián G McNicholl
ABSTRACT

Helicobacter pylori eradication is a challenge in penicillin allergy. To assess the efficacy and safety of first-line and rescue treatments in patients allergic to penicillin. Prospective multicenter study. Patients allergic to penicillin were given a first-line treatment comprising (a) 7-day omeprazole-clarithromycin-metronidazole and (b) 10-day omeprazole-bismuth-tetracycline-metronidazole. Rescue treatments were as follows: (a) bismuth quadruple therapy; (b) 10-day PPI-clarithromycin-levofloxacin; and (c) 10-day PPI-clarithromycin-rifabutin. Eradication was confirmed by (13)C-urea breath test. Compliance was determined through questioning and recovery of empty medication envelopes. Adverse effects were evaluated by questionnaires. In total, 267 consecutive treatments were included. (1) First-line treatment: Per-protocol and intention-to-treat eradication rates with omeprazole-clarithromycin-metronidazole were 59 % (62/105; 95 % CI 49-62 %) and 57 % (64/112; 95 % CI 47-67 %). Respective figures for PPI-bismuth-tetracycline-metronidazole were 75 % (37/49; 95 % CI 62-89 %) and 74 % (37/50; 95 % CI (61-87 %) (p < 0.05). Compliance with treatment was 94 and 98 %, respectively. Adverse events were reported in 14 % with both regimens (all mild). (2) Second-line treatment: Intention-to-treat eradication rate with omeprazole-clarithromycin-levofloxacin was 64 % both after triple and quadruple failure; compliance was 88-100 %, with 23-29 % adverse effects (all mild). (3) Third-/fourth-line treatment: Intention-to-treat eradication rate with PPI-clarithromycin-rifabutin was 22 %. In allergic to penicillin patients, a first-line treatment with a bismuth-containing quadruple therapy (PPI-bismuth-tetracycline-metronidazole) seems to be a better option than the triple PPI-clarithromycin-metronidazole regimen. A levofloxacin-based regimen (together with a PPI and clarithromycin) represents a second-line rescue option in the presence of penicillin allergy.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
Clarithromycin, ≥95% (HPLC)
Supelco
Metronidazole, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Clarithromycin, Pharmaceutical Secondary Standard; Certified Reference Material
Supelco
Metronidazole, VETRANAL®, analytical standard
Sigma-Aldrich
Clarithromycin, 96.0-102.0% (HPLC)
Sigma-Aldrich
Tetracycline, 98.0-102.0% (HPLC)
Clarithromycin for peak identification, European Pharmacopoeia (EP) Reference Standard
USP
Clarithromycin, United States Pharmacopeia (USP) Reference Standard
Clarithromycin, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Tetracycline, 98.0-102.0% (HPLC)
Supelco
Metronidazole, analytical standard
Sigma-Aldrich
Metronidazole, SAJ first grade, ≥99.0%
Sigma-Aldrich
Rifabutin, >98% (HPLC), powder
Sigma-Aldrich
Metronidazole, BioXtra
USP
Rifabutin, United States Pharmacopeia (USP) Reference Standard
Metronidazole, European Pharmacopoeia (EP) Reference Standard
Rifabutin, European Pharmacopoeia (EP) Reference Standard
Supelco
Omeprazole, analytical standard
Bismuth, foil, not light tested, 25x25mm, thickness 0.001mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 25x25mm, thickness 0.02mm, permanent polyester support, 99.97%
Supelco
Levofloxacin, analytical standard
Tetracycline hydrochloride, European Pharmacopoeia (EP) Reference Standard
Bismuth, foil, light tested, 25x25mm, thickness 0.015mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 150x150mm, thickness 0.02mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 50x50mm, thickness 0.0025mm, permanent polyester support, 99.97%
Bismuth, foil, light tested, 50x50mm, thickness 0.025mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 150x150mm, thickness 0.05mm, permanent polyester support, 99.97%
Bismuth, foil, light tested, 50x50mm, thickness 0.01mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 50x50mm, thickness 0.002mm, permanent polyester support, 99.97%
Bismuth, foil, not light tested, 25x25mm, thickness 0.0025mm, permanent polyester support, 99.97%